Label: CLEAN AND CLEAR ADVANTAGE ACNE CONTROL- benzoyl peroxide kit

  • NDC Code(s): 69968-0032-1, 69968-0033-1, 69968-0034-9
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 21, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Clean & Clear Advantage Acne Control Cleanser

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne treatment

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth. If contact occurs, flush thoroughly with water.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide.

    Stop use and ask a doctor if

    • irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet face. Gently massage all over face, avoiding eye area. Rinse thoroughly and pat dry.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    • Store at 20°C to 25°C (68°F - 77°F)
  • Inactive ingredients

    Water, Cetyl Alcohol, Petrolatum, Zinc Lactate, Steareth-2, Glycerin, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Benzyl Alcohol, Fragrance, Disodium EDTA, Laureth-4, BHT, Menthol

  • Questions?

    Call toll-free 877-754-6411 or215-273-8755 (collect) or visit www.CleanandClear.com

  • SPL UNCLASSIFIED SECTION

    Clean & Clear Advantage Fast Acting Treatment

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 2.5%

  • Purpose

    Acne treatment

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth. If contact occurs, flush thoroughly with water.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide.

    Stop use and ask a doctor if

    • irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Cleanse skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer one to three times daily
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    • Store at 20°C to 25°C (68°F - 77°F)
  • Inactive ingredients

    Water, Carbomer Homopolymer type B, Ethylhexylglycerin, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Laureth-4, Hydroxypropyl Methylcellulose

  • Questions?

    Call toll-free 877-754-6411 or215-273-8755 (collect) or visit www.CleanandClear.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558-9418

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NEW
    Clean &
    Clear ®

    advantage
    acne control kit

    CLEANSE               TREAT         MOISTURIZE

    works so fast, pimples hurt less in
    2 hours and look better in 4 hours
    With use of the fast acting treatment
    cleanse to remove dirt and oil
    treat problem areas and pimples
    moisturize to leave skin soft and smooth

    includes a
    HYDRATING
    MOISTURIZER FOR
    LESS DRYNESS
    AND LESS
    IRRIGATION

    Convenience kit
    NET WT. 4 OZ. (113 g) benzoyl peroxide acne cleanser
    NET WT. 1 OZ. (28 g) benzoyl peroxide acne treatment
    NET WT. 2 OZ. (56 g) hydrating gel moisturizer

    Johnson & Johnson

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLEAN AND CLEAR ADVANTAGE ACNE CONTROL 
    benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0034
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0034-91 in 1 CARTON11/05/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 113 g
    Part 21 TUBE 28 g
    Part 31 TUBE 56 g
    Part 1 of 3
    CLEAN AND CLEAR ADVANTAGE ACNE CONTROL CLEANSER 
    benzoyl peroxide cream
    Product Information
    Item Code (Source)NDC:69968-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0033-1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2015
    Part 2 of 3
    CLEAN AND CLEAR ADVANTAGE FAST ACTING TREATMENT 
    benzoyl peroxide gel
    Product Information
    Item Code (Source)NDC:69968-0032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-4 (UNII: 6HQ855798J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0032-128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2015
    Part 3 of 3
    CLEAN AND CLEAR ADVANTAGE HYDRATING GEL MOISTURIZER 
    moisturizing gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCETEARYL OLIVATE (UNII: 58B69Q84JO)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRSORBITAN OLIVATE (UNII: MDL271E3GR)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRLAURETH-7 (UNII: Z95S6G8201)  
    INGRC12-14 PARETH-12 (UNII: M0LJS773XW)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/05/2015
    Labeler - Johnson & Johnson Consumer Inc. (002347102)